Division

SEC Charges Florida Payday Lender and CEO with Affinity Fraud Targeting the Venezuelan-American Community

Monday, September 27, 2021 - 4:43pm

Sky Group and Betancourt also allegedly used at least $19.2 million of investors' money to make Ponzi-like payments to other investors.

Key Points: 
  • Sky Group and Betancourt also allegedly used at least $19.2 million of investors' money to make Ponzi-like payments to other investors.
  • "We continue to caution investors to be wary of any investment that promises returns that are too good to be true."
  • The SEC's complaint charges Sky Group and Betancourt with violations of the registration and antifraud provisions of the federal securities laws and additionally charges Betancourt with acting as an unregistered broker.
  • The SEC appreciates the assistance of the Florida Office of Financial Regulation.

Susan G. Komen® Recognizes Renowned Investigators as 2021 Recipients of Brinker Awards for Scientific Distinction

Monday, September 27, 2021 - 4:51pm

This years Brinker Award for Scientific Distinction in Basic Science will be presented to Carlos Caldas, M.D., FMedSci, Professor of Cancer Medicine at the University of Cambridge.

Key Points: 
  • This years Brinker Award for Scientific Distinction in Basic Science will be presented to Carlos Caldas, M.D., FMedSci, Professor of Cancer Medicine at the University of Cambridge.
  • This work helped define molecular subtypes (or groups) of breast cancer and identify the genomic changes that drive tumor growth.
  • To date, Komen has invested more than $1.1 billion in breast cancer research, making it the largest nonprofit funder of breast cancer research outside of the U.S. government.
  • Susan G. Komen is the worlds leading nonprofit breast cancer organization, working to save lives and end breast cancer forever.

Cannabis use by pregnant women increased during pandemic

Monday, September 27, 2021 - 4:00pm

The study found that in the year before the pandemic, 6.75% of pregnant women were using cannabis in early pregnancy, and during the pandemic that rate rose to 8.14% of pregnant women.

Key Points: 
  • The study found that in the year before the pandemic, 6.75% of pregnant women were using cannabis in early pregnancy, and during the pandemic that rate rose to 8.14% of pregnant women.
  • The study did not determine why more pregnant women might be using cannabis.
  • "Our previous research has shown that the prevalence and frequency of prenatal cannabis use is increasing over time and that pregnant women are more likely to use cannabis if they are depressed, anxious, or have experienced trauma.
  • "The stay-at-home mandates, concerns about getting COVID-19, economic challenges, increased child care burden, and other difficult aspects of the pandemic could contribute to pregnant women feeling more stressed and depressed during this time," Young-Wolff added.

Blue Earth Diagnostics Announces Results of an Analysis of the Impact of Axumin® (Fluciclovine F 18) PET/CT Imaging on Androgen Deprivation Therapy (ADT) Planning in Recurrent Prostate Cancer

Monday, September 27, 2021 - 1:30pm

This analysis characterized the impact of Axumin PET/CT on sites of disease recurrence and plans for androgen deprivation therapy (ADT) in patients with biochemical recurrence of prostate cancer.

Key Points: 
  • This analysis characterized the impact of Axumin PET/CT on sites of disease recurrence and plans for androgen deprivation therapy (ADT) in patients with biochemical recurrence of prostate cancer.
  • Of 60 patients originally planned for ADT monotherapy, only 25% (15) were still due to receive ADT monotherapy after Axumin PET/CT imaging.
  • Axumin, a novel amino acid-based radiopharmaceutical, is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.
  • Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy.

vTv Therapeutics Announces Results of Multiple Ascending Dose Study and Development Plan for HPP737, an Oral PDE4 Inhibitor for the Treatment of Psoriasis

Thursday, September 23, 2021 - 9:30pm

HIGH POINT, N.C., Sept. 23, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT) a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes and psoriasis, today announced results of a multiple ascending dose study evaluating HPP737, an orally administered phosphodiesterase type 4 (“PDE4”) inhibitor, in healthy adults. The trial enrolled 12 subjects in each of two dose cohorts, 15mg and 20mg, randomized to receive HPP737 or placebo (3:1) orally once daily for 14 days. Dose escalation up to 20mg/day demonstrated approximate dose proportional increases in exposure, while maintaining a favorable safety and tolerability profile with no dose limiting safety or tolerability findings observed. There were no serious adverse events and no discontinuations due to treatment emergent adverse events. vTv therefore believes that the current safety profile allows it to move forward in development with a drug that may achieve anti-inflammatory and anti-psoriatic responses without the significant safety issues of other PDE4 inhibitors. Results of the two multiple ascending dose studies conducted by vTv to date will be presented at an upcoming scientific conference focused on dermatology.

Key Points: 
  • Results of the two multiple ascending dose studies conducted by vTv to date will be presented at an upcoming scientific conference focused on dermatology.
  • With these results, vTv held a successful pre-IND meeting with the U.S. Food and Drug Administration Division of Dermatology and Dentistry.
  • An oral, once-daily PDE4 inhibitor with robust efficacy, absent adverse events of gastrointestinal distress, would be a significant benefit for patients with psoriasis.
  • vTv has a pipeline of clinical drug candidates led by programs for the treatment of type 1 diabetes and psoriasis.

SEC Issues Agenda for Sept. 27 Meeting of the Asset Management Advisory Committee

Thursday, September 23, 2021 - 8:23pm

Washington, D.C.--(Newsfile Corp. - September 23, 2021) - The Securities and Exchange Commission today released the agenda for the Sept. 27 meeting of the Asset Management Advisory Committee (AMAC).

Key Points: 
  • Washington, D.C.--(Newsfile Corp. - September 23, 2021) - The Securities and Exchange Commission today released the agenda for the Sept. 27 meeting of the Asset Management Advisory Committee (AMAC).
  • The meeting will be held by remote means and is open to the public.
  • The meeting will be webcast live on the SEC's website, www.sec.gov , and will be archived on the website for later viewing.
  • Asset Management Advisory Committee Agenda for Sept. 27, 2021, Meeting
    Chair Gensler; Commissioners Peirce, Roisman, and Lee; Sarah ten Siethoff, Acting Director of the Division of Investment Management; and Ed Bernard, Committee Chairman

Cytokinetics to Host Analyst & Investor Day on October 7, 2021

Thursday, September 23, 2021 - 9:00pm

SOUTH SAN FRANCISCO, Calif., Sept. 23, 2021 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK), today announced that it will host an Analyst and Investor Day on Thursday, October 7, 2021 from 8:30 AM to 11:30 AM ET.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Sept. 23, 2021 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK), today announced that it will host an Analyst and Investor Day on Thursday, October 7, 2021 from 8:30 AM to 11:30 AM ET.
  • Members of Cytokinetics senior management will be joined by expert clinicians to provide updates on the companys plans for commercialization and advancing cardiovascular pipeline.
  • Registered attendees may access the live virtual event on the Investors & Media section of Cytokinetics website at www.cytokinetics.com .
  • Cytokinetics expects to start a Phase 3 clinical trial of aficamten in patients with obstructive HCM in Q4 2021.

NOVA's New Vice President of Academic Affairs and Chief Academic Officer Unveils His Priorities for the College

Thursday, September 23, 2021 - 8:00pm

ANNANDALE, Va., Sept. 23, 2021 /PRNewswire-PRWeb/ -- Dr. Eun-Woo Chang joined NOVA this summer as VP of Academic Affairs and Chief Academic Officer.

Key Points: 
  • ANNANDALE, Va., Sept. 23, 2021 /PRNewswire-PRWeb/ -- Dr. Eun-Woo Chang joined NOVA this summer as VP of Academic Affairs and Chief Academic Officer.
  • Having gotten the lay of the land, he has now released his priorities for the college: to implement innovation, diversity and inclusivity into all facets of academic planning.
  • He previously served in academic leadership at Ashland University and Mercer County Community College.
  • This college has always been a great incubator for inclusive education, and I want to encourage innovation," said Chang.

TG Therapeutics Announces Publication of Results from an Integrated Safety Analysis of UKONIQ® (umbralisib) in Blood Advances

Thursday, September 23, 2021 - 1:00pm

Michael S. Weiss, the Companys Chairman and Chief Executive Officer stated, We are pleased that the integrated safety analysis of 371 patients treated with UKONIQ has been published in Blood Advances.

Key Points: 
  • Michael S. Weiss, the Companys Chairman and Chief Executive Officer stated, We are pleased that the integrated safety analysis of 371 patients treated with UKONIQ has been published in Blood Advances.
  • The integrated safety data analysis of umbralisib published [today/yesterday] is encouraging for patients, especially given the low rate of discontinuations due to adverse events observed.
  • These data are described further in the manuscript entitled, Integrated safety analysis of umbralisib, a dual PI3K/CK1 inhibitor, in relapsed/refractory lymphoid malignancies, which was published online in Blood Advances.
  • UKONIQ is a trademark ofTG Therapeutics, Inc.
    UKONIQ is the first and onlyoral inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1(CK1) epsilon.

TFF Pharmaceuticals Announces Promising Topline Results from Phase 1 Clinical Trial of Inhaled Tacrolimus Powder and Progression Toward Phase 2 in Lung Transplantation

Thursday, September 23, 2021 - 1:00pm

This flexible dosing approach will also be reflected in the design for our upcoming Phase 2 study in lung transplant recipients.

Key Points: 
  • This flexible dosing approach will also be reflected in the design for our upcoming Phase 2 study in lung transplant recipients.
  • The eight subjects in each cohort included six subjects randomized to receive tacrolimus and two randomized to receive placebo.
  • TFF Pharmaceuticals expects to take critical steps toward beginning its Phase 2 clinical study of Inhaled Tacrolimus Powder by the end of 2021.
  • It is exciting for our patients and for us as clinicians to have a potential new option with Inhaled Tacrolimus Powder.